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ARTICLE |

The Nation's Changing Blood Supply System FREE

Jeffrey McCullough, MD
[+] Author Affiliations

Reprint requests to Department of Laboratory Medicine and Pathology, University of Minnesota Hospital and Clinic, 420 Delaware St SE, Minneapolis, MN 55455 (Dr McCullough).


JAMA. 1993;269(17):2239-2245. doi:10.1001/jama.1993.03500170069036
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DURING the past several years, great interest has developed in the safety of the blood supply in the United States and the manner in which our nation's blood supply is obtained and distributed. Today, this country's blood bank system finds itself in a changed regulatory environment; under considerable public scrutiny; carrying out a much larger, more complex work load; in a more litigious environment; with an organizational infrastructure in need of strengthening at a time of increasing cost constraints; and viewed by some as having inadequately responded to the issues of the 1980s. The manner and effectiveness with which the present issues in blood banking are resolved will have a major impact on the system used to obtain the nation's blood supply and the safety, adequacy, and cost of that supply. This article examines the present issues of concern in the US blood banking system and describes how the outcome

REFERENCES

Wallace EL, Surgenor DM, Hao HS, An J, Chapman RH, Churchill WH.  Collection and transfusion of blood and blood components in the United States, 1989. Transfusion . 1993;;33:139-144.
Busch MP, Holland PV.  Idiopathic CD4+ T-lymphocytopenia (ICL) and the safety of blood transfusions: what do we know and what should we do? Transfusion . 1992;;32:800-804.
Cumming PD, Wallace EL, Schorr JB, Dodd RY.  Exposure of patients to human immunodeficiency virus through the transfusion of blood components that test antibody-negative. N Engl J Med . 1989;;321:941-946.
Busch MP, Bernard EE, Khayam-Bashi H, et al.  Evaluation of screened blood donations from human immunodeficiency virus type 1 infection by culture and DNA amplification of pooled cells. N Engl J Med . 1991;;325:1-5.
Donahue JG, Munoz A, Ness PM, et al.  The declining risk of post-transfusion hepatitis C virus infection. N Engl J Med . 1992;;327:369-373.
Dodd RY.  The risk of transfusion-transmitted infection. N Engl J Med . 1992;;327:419-421.
Nelson KE, Donahue JG, Munoz A, et al.  Transmission of retroviruses from seronegative donors by transfusion during cardiac surgery. Ann Intern Med . 1992;;117:554-559.
Kleinman S, Alter H, Busch M, et al.  Increased detection of hepatitis C virus (HCV)-infected blood donors by a multiple-antigen HCV enzyme immunoassay. Transfusion . 1992;;32:805-813.
Busch MP, Young MJ, Samson SJ, et al.  Risk of human immunodeficiency virus (HIV) transmission by blood transfusions before the implementation of HIV-1 antibody screening. Transfusion . 1991;;31: 4-11.
MacPherson JL, Beaston LB, eds.  Adequacy of the nation's blood supply.  In: Proceedings from a national conference sponsored by the American Blood Commission and the Council of Community Blood Centers ; February 18, 1990;; Clearwater, Fla.
Gaul GM.  How blood, the `gift of life,' became a billion-dollar business. Philadelphia Inquirer . September 24, 1989;;320( (267) ):41.
Hearings Before the Subcommittee on Oversight and Investigations of the Committee on Energy and Commerce, House of Representatives , 102nd Cong, 1st Sess (April 18, 1991;; May 15,1991) (blood supply safety).
Surgenor DM, Wallace EL, Hao SHS, Chapman RH.  Collection and transfusion of blood in the United States, 1982-1988. N Engl J Med . 1990;;322: 1646-1651.
Silberstein LE, Kruskall MS, Stehling LC, et al.  Strategies for the review of transfusion practices. JAMA . 1989;;262;1993-1997.
Grindon AJ.  Infectious disease markers in directed donors in the Atlanta region. Transfusion . 1991;;31:872-873.
Brecher ME, Borchers G, Rosen N, Lord M.  Directed donations: an underutilized blood donor resource. Lab Med . 1988;;19:103-105.
Starkey JM, MacPherson JL, Bolgiano DC, Simon ER, Zuck TF, Sayers MH.  Markers for transfusion-transmitted disease in different groups of blood donors. JAMA . 1989;;262:3452-3454.
Williams AE, Kleinman S, Gilcher RO, et al.  The prevalence of infectious disease markers in directed versus homologous blood donations. Transfusion . 1992;;32:455. Abstract.
Centers for Disease Control and Prevention.  AIDS and human immunodeficiency virus infection in the United States: 1988 update. MMWR . 1989;; 38:11-12.
Nightingale SL.  The second 100 000 cases of acquired immunodeficiency syndrome—United States. MMWR . 1992;;41:28-29.
Klein RS.  Transmission of human immunodeficiency virus type 1 (HIV-1) by exposure to blood: defining the risk. Ann Intern Med . 1990;;113:729-730.
Sayers MH.  Duties to donors. Transfusion . 1992;; 32:465-466.
Grossman BJ, Springer KM.  Blood donor deferral registries: highlights of a conference. Transfusion . 1992;;32:868-872.
Moyer LA, Shapiro CN, Shulman G, Brugliera PD, Alter MJ.  A survey of hepatitis B surface antigen positive blood donors: degree of understanding and action taken after notification. Transfusion . 1992;;32:702-706.
Solomon JM.  Legislation and regulation in blood banking.  In: Schaeffer M, ed. Federal Legislation and the Clinical Laboratory . Boston, Mass: GK Hall Medical Publishers; 1981;:143-171.
Gladwell M.  FDA bolsters generic drug supervision, fraud has tarnished agency's credibility. Washington Post . (August 19) , 1989;.
Ingersoll B.  FDA panel charges Pfizer unit sought to prolong sale of fraud heart valve. Wall Street J . (September 13) , 1991;.
Gaul GM.  The loose way the FDA regulates blood industry. Philadelphia Inquirer . (September 25) , 1989;:A1, A8.
Hilts PJ.  Red Cross orders sweeping changes at blood centers. New York Times . (May 20) , 1991;: A1, A6.
Zeckhauser RJ, Viscusi WK.  Risk within reason. Science . 1990;;248:559-564.
Dinman BD.  The reality and acceptance of risk. JAMA . 1980;;244:1226-1228.
Freudenburg WR.  Perceived risk, real risk: social science and the art of probabilistic risk assessment. Science . 1988;;242:44-49.
Cates W, Hinman AR.  AIDS and absolutism— the demand for perfection in prevention. N Engl J Med . 1992;;327:492-494.
Birkmeyer JD, Goodnough LT, AuBuchon JP, Noordsij PG, Littenberg B.  The cost-effectiveness of preoperative autologous blood donation in total hip and knee replacement. Transfusion . In press.

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Wallace EL, Surgenor DM, Hao HS, An J, Chapman RH, Churchill WH.  Collection and transfusion of blood and blood components in the United States, 1989. Transfusion . 1993;;33:139-144.
Busch MP, Holland PV.  Idiopathic CD4+ T-lymphocytopenia (ICL) and the safety of blood transfusions: what do we know and what should we do? Transfusion . 1992;;32:800-804.
Cumming PD, Wallace EL, Schorr JB, Dodd RY.  Exposure of patients to human immunodeficiency virus through the transfusion of blood components that test antibody-negative. N Engl J Med . 1989;;321:941-946.
Busch MP, Bernard EE, Khayam-Bashi H, et al.  Evaluation of screened blood donations from human immunodeficiency virus type 1 infection by culture and DNA amplification of pooled cells. N Engl J Med . 1991;;325:1-5.
Donahue JG, Munoz A, Ness PM, et al.  The declining risk of post-transfusion hepatitis C virus infection. N Engl J Med . 1992;;327:369-373.
Dodd RY.  The risk of transfusion-transmitted infection. N Engl J Med . 1992;;327:419-421.
Nelson KE, Donahue JG, Munoz A, et al.  Transmission of retroviruses from seronegative donors by transfusion during cardiac surgery. Ann Intern Med . 1992;;117:554-559.
Kleinman S, Alter H, Busch M, et al.  Increased detection of hepatitis C virus (HCV)-infected blood donors by a multiple-antigen HCV enzyme immunoassay. Transfusion . 1992;;32:805-813.
Busch MP, Young MJ, Samson SJ, et al.  Risk of human immunodeficiency virus (HIV) transmission by blood transfusions before the implementation of HIV-1 antibody screening. Transfusion . 1991;;31: 4-11.
MacPherson JL, Beaston LB, eds.  Adequacy of the nation's blood supply.  In: Proceedings from a national conference sponsored by the American Blood Commission and the Council of Community Blood Centers ; February 18, 1990;; Clearwater, Fla.
Gaul GM.  How blood, the `gift of life,' became a billion-dollar business. Philadelphia Inquirer . September 24, 1989;;320( (267) ):41.
Hearings Before the Subcommittee on Oversight and Investigations of the Committee on Energy and Commerce, House of Representatives , 102nd Cong, 1st Sess (April 18, 1991;; May 15,1991) (blood supply safety).
Surgenor DM, Wallace EL, Hao SHS, Chapman RH.  Collection and transfusion of blood in the United States, 1982-1988. N Engl J Med . 1990;;322: 1646-1651.
Silberstein LE, Kruskall MS, Stehling LC, et al.  Strategies for the review of transfusion practices. JAMA . 1989;;262;1993-1997.
Grindon AJ.  Infectious disease markers in directed donors in the Atlanta region. Transfusion . 1991;;31:872-873.
Brecher ME, Borchers G, Rosen N, Lord M.  Directed donations: an underutilized blood donor resource. Lab Med . 1988;;19:103-105.
Starkey JM, MacPherson JL, Bolgiano DC, Simon ER, Zuck TF, Sayers MH.  Markers for transfusion-transmitted disease in different groups of blood donors. JAMA . 1989;;262:3452-3454.
Williams AE, Kleinman S, Gilcher RO, et al.  The prevalence of infectious disease markers in directed versus homologous blood donations. Transfusion . 1992;;32:455. Abstract.
Centers for Disease Control and Prevention.  AIDS and human immunodeficiency virus infection in the United States: 1988 update. MMWR . 1989;; 38:11-12.
Nightingale SL.  The second 100 000 cases of acquired immunodeficiency syndrome—United States. MMWR . 1992;;41:28-29.
Klein RS.  Transmission of human immunodeficiency virus type 1 (HIV-1) by exposure to blood: defining the risk. Ann Intern Med . 1990;;113:729-730.
Sayers MH.  Duties to donors. Transfusion . 1992;; 32:465-466.
Grossman BJ, Springer KM.  Blood donor deferral registries: highlights of a conference. Transfusion . 1992;;32:868-872.
Moyer LA, Shapiro CN, Shulman G, Brugliera PD, Alter MJ.  A survey of hepatitis B surface antigen positive blood donors: degree of understanding and action taken after notification. Transfusion . 1992;;32:702-706.
Solomon JM.  Legislation and regulation in blood banking.  In: Schaeffer M, ed. Federal Legislation and the Clinical Laboratory . Boston, Mass: GK Hall Medical Publishers; 1981;:143-171.
Gladwell M.  FDA bolsters generic drug supervision, fraud has tarnished agency's credibility. Washington Post . (August 19) , 1989;.
Ingersoll B.  FDA panel charges Pfizer unit sought to prolong sale of fraud heart valve. Wall Street J . (September 13) , 1991;.
Gaul GM.  The loose way the FDA regulates blood industry. Philadelphia Inquirer . (September 25) , 1989;:A1, A8.
Hilts PJ.  Red Cross orders sweeping changes at blood centers. New York Times . (May 20) , 1991;: A1, A6.
Zeckhauser RJ, Viscusi WK.  Risk within reason. Science . 1990;;248:559-564.
Dinman BD.  The reality and acceptance of risk. JAMA . 1980;;244:1226-1228.
Freudenburg WR.  Perceived risk, real risk: social science and the art of probabilistic risk assessment. Science . 1988;;242:44-49.
Cates W, Hinman AR.  AIDS and absolutism— the demand for perfection in prevention. N Engl J Med . 1992;;327:492-494.
Birkmeyer JD, Goodnough LT, AuBuchon JP, Noordsij PG, Littenberg B.  The cost-effectiveness of preoperative autologous blood donation in total hip and knee replacement. Transfusion . In press.
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